Chemical and Clinical Supply
ChemDiv has the chemical equipment and experienced personnel to scale up the Active Pharmaceutical Ingredients (API) to meet all regulatory requirements suitable for administration to human subjects. The state of the art facility can handle quantities up to several kilograms and has the full capability to conduct purity and stability analysis. We offer extensive pre-formulation and biopharmaceutical support between candidate identification and clinical development.
These services include solid characterization, solution characterization, excipient compatibility, accelerated stability, chiral stability.
ChemDiv has capabilities in formulation development for dosage forms, troubleshooting and process development of existing dosage forms, optimization of existing formulations, and qualitative/quantitative evaluation of proprietary dosage forms. Dosage forms include solids (tablets, capsules, sustained release and coatings), semi-solids (ointments, creams, gels), dispersed systems (emulsions, suspensions), and liquids (orals, ophthalmic).
Analytical capabilities include method development, qualification and validation, raw material testing, stability sample analysis, dissolution testing, residual solvent analysis, chiral determination, cleaning evaluations, and technical packages for drug substances.
Clinical supplies manufacturing capabilities include API into capsule, tablets and capsules, liquid in capsule, semi-solids, and non-sterile liquid. In addition, we provide reference product blinding, packaging and labeling services, and offer expertise in creation of matching placebo formulation, creation and qualification of blinded reference product, process qualification, process definition optimization, and technology transfer.
ChemDiv gathers information from our clients to establish the correct parameters of our stability studies, including appropriate test conditions, the duration of the stability study, the testing intervals, and the analytical methods. These processes vary with the type of product and type of study, scientific or regulatory, and ChemDiv has extensive experience with both.
To read about our strategic design of an integrated CMC development plan, click here.
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